Trial · NCT02949973
Aurinia Early Urinary Protein Reduction Predicts Response
NCT02949973, Phase 2, Completed, Aurinia Pharmaceuticals Inc.; results first posted 2021-03-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Aurinia Early Urinary Protein Reduction Predicts Response. Trials, record NCT02949973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02949973
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aurinia Early Urinary Protein Reduction Predicts Response
- NCT number
- NCT02949973
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Conditions
- Lupus Nephritis
- Interventions
- voclosporin
- First posted
- 2016-10-31
- Last updated
- 2021-03-19
- Results first posted
- 2021-03-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR) | 24 weeks | |
| Primary | Number of Participants With Reduction or Normalization of Anti ds DNA | 24 weeks | |
| Primary | Number of Participants With Reduction or Normalization of C3 | 24 weeks | |
| Primary | Number of Participants With Reduction or Normalization of C4 | 24 weeks | |
| Secondary | Number of Participants With Complete Remission at Week 24 | week 24 | * Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20% |
| Secondary | Number of Participants With Complete Remission at Week 48 | week 48 | * Confirmed Protein/creatinine ratio of ≤0.5 mg/mg and * eGFR ≥ 60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of ≥20% Safety Population - 2 subjects failed to provide sufficient data to ascertain week 48 response |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR) | 24 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Reduction or Normalization of Anti ds DNA | 24 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Reduction or Normalization of C3 | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Reduction or Normalization of C4 | 24 weeks | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Remission at Week 24 | week 24 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Remission at Week 48 | week 48 | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Reduction or Normalization of Urine Protein/Creatinine Ratio (UPCR) | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 7 | Participants | ||
| Number of Participants With Reduction or Normalization of Anti ds DNA | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 4 | Participants | ||
| Number of Participants With Reduction or Normalization of C3 | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 2 | Participants | ||
| Number of Participants With Reduction or Normalization of C4 | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 2 | Participants | ||
| Number of Participants With Complete Remission at Week 24 | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 7 | Participants | ||
| Number of Participants With Complete Remission at Week 48 | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 10 | |
| Overall Study | COMPLETED | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 9 | |
| Overall Study | NOT COMPLETED | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 | 10 | 1 |
| other | Palpitations | Cardiac disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 | 10 | 1 |
| other | Otorrhoea | Ear and labyrinth disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 | 10 | 2 |
| other | Cushingoid | Endocrine disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 | 10 | 1 |
| other | Chalazion | Eye disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 | 10 | 1 |
| other | Conjunctival Haemorrhage | Eye disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 | 10 | 1 |
| other | Eyelid Oedema | Eye disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 1 | 10 | 1 |
| other | Vision Blurred | Eye disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 2 | 10 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 4 | 10 | 6 |
| other | Dyspepsia | Gastrointestinal disorders | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 2 | 10 | 2 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 0 | 10 |
| Total, other adverse events | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 10 | 10 |
| Total, serious adverse events | Voclosporin 23.7 mg Twice Daily (BID) in Combination With Standard of Care | 3 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02949973
GET https://conductscience.org/api/trials/v1/NCT02949973/events?page=2